Bacteriophage Therapy for Mycobacterium Abscessus Pulmonary Infection: An Open Label Individual Patient Study
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Microbiologic: Response
研究概览
简要总结
This study aims to use mycobacteriophage therapy, using identified in-vitro effective Mycobacteriophage Muddy_HRMN0052, along with combination conventional antimycobacterial therapy for their NTM pulmonary disease with Mycobacterium abscessus with goal to reduce infection burden and improve pulmonary disease
详细描述
Hypothesis
Hypothesis: Mycobacteriophage therapy, using identified in-vitro effective Mycobacteriophage Muddy_HRMN0052, along with combination conventional antimycobacterial therapy for their NTM pulmonary disease with MABS will reduce infection burden and improve pulmonary disease.
Objectives:
- Efficacy - Assess MABS pulmonary disease response mycobacteriophage therapy
- Safety - Determine tolerability and off target effects of IV and inhaled mycobacteriophage therapy
Specific End Points (during and post treatment up to last clinical follow-up (>24month):
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •This is an individual patient expanded access study specific to one individual based on tailor intervention (Mycobacteriophage)
- •Inclusion Criteria:
- •consent to participation
排除标准
- •non-consent to participation
研究组 & 干预措施
Treatment
Use of mycobacteriophage
干预措施: Mycobacteriophage Muddy_HRMN0052 (Biological)
Treatment
Use of mycobacteriophage
干预措施: Amikacin Injection (Drug)
Treatment
Use of mycobacteriophage
干预措施: Clofazimine (Drug)
Treatment
Use of mycobacteriophage
干预措施: Bedaquiline (B) (Drug)
Treatment
Use of mycobacteriophage
干预措施: Linezolid (LZD) (Drug)
Treatment
Use of mycobacteriophage
干预措施: Sulfamethoxazole/Trimethoprim (Drug)
结局指标
主要结局
Microbiologic: Response
时间窗: 2 years
1\. Sputum culture status: time (days) to durable sputum culture conversion (no mycobacterial growth on 3 sputum sample)
次要结局
- Microbiologic: Resistance development(2 years)
- Clinical: Symptoms(2 year)
- Clinical: Sputum(2 year)
- Clinical: Radiographic(2 year)
- Clinical: Pulmonary Function(2 year)
- Clinical: Symptoms(2 year)
- Clinical: Sputum(2 year)
- Microbiologic: Resistance development(2 years)
- Clinical: Radiographic(2 year)
- Clinical: Pulmonary Function(2 year)
- Microbiologic: Neutralizing antibody status.(2 years)
- Clinical: Adverse effects(2 year)
研究者
William Connors
Clinical Associate Professor
Vancouver Coastal Health